Dressing: Frequency of Change and Evaluation of an Antiseptic-Impregnated Catheter Dressing in ICU Patients - Full Text View

Sponsor:	University Hospital, Grenoble
Collaborator:	Ministry of Health, France
Information provided by:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT00417235

Purpose

The purpose of this study is to determine whether a catheter dressing every 7th day is not inferior to a catheter dressing every 3 days and if Chlorhexidine impregnated sponges are effective in preventing catheter-related infections in ICUs.

Condition	Intervention	Phase
Systemic Inflammatory Response Syndrome Bacteremia	Device: Chlorhexidine Sponge (Biopatch TM) Behavioral: 3-day or 7-day catheter dressing frequency	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	Dressing: Comparison of 3-Day and 7-Day Catheter Dressing Frequency and Efficacy of Antiseptic Impregnated Dressing in Preventing Catheter-Related Infection in ICU

Resource links provided by NLM:

MedlinePlus related topics: Sepsis

Drug Information available for: Chlorhexidine Chlorhexidine digluconate Hibiclens

U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:

Systemic catheter related sepsis as defined by a blinded expert panels to unmask differences between Chlorhexidine dressings and no Chlorhexidine dressings [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Significant catheter culture >=103 cfu/ml for non inferiority between 7 days and 3 day catheter-dressing frequencies [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

catheter related septicemia [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
cutaneous allergy [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
cost [ Time Frame: within the 60 days after catheter insertion ] [ Designated as safety issue: No ]

Estimated Enrollment:	1600
Study Start Date:	January 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention 3-days chlorexidrine impregnated sponge	Device: Chlorhexidine Sponge (Biopatch TM) dressing with chlorexidrine sponge versus dressing without chlorexidrine sponge Behavioral: 3-day or 7-day catheter dressing frequency dressing changes every 7 days versus every 3 days
3: No Intervention 7-days chlorexidrine impregnated sponge	Device: Chlorhexidine Sponge (Biopatch TM) dressing with chlorexidrine sponge versus dressing without chlorexidrine sponge Behavioral: 3-day or 7-day catheter dressing frequency dressing changes every 7 days versus every 3 days
2: No Intervention 3-days without chlorexidrine impregnated sponge	Device: Chlorhexidine Sponge (Biopatch TM) dressing with chlorexidrine sponge versus dressing without chlorexidrine sponge Behavioral: 3-day or 7-day catheter dressing frequency dressing changes every 7 days versus every 3 days
4: No Intervention 7 days without chlorexidrine impregnated sponge	Device: Chlorhexidine Sponge (Biopatch TM) dressing with chlorexidrine sponge versus dressing without chlorexidrine sponge Behavioral: 3-day or 7-day catheter dressing frequency dressing changes every 7 days versus every 3 days

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients older than 18 years
with at least a central venous catheter or an arterial catheter
whatever the first or subsequent CVC in a same patient
in any site of insertion (sub-clavian, jugular or femoral)
whatever le CVC is tunnelled or not
CVC inserted in the study ICU or immediately before by the intensisvist in the emergency unit or in the operative room,
CVC inserted under maximal barrier precautions

Exclusion Criteria:

pulmonary artery catheter, haemodialysis/haemodiafiltration CVCs
known allergy to chlorhexidine
CVC not inserted under maximal barrier precautions
Expected duration of CVC for less than 48 hours
CVC inserted under emergency conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417235

Locations

France
grenoble university hospital (medical ICU and surgical ICU)
Grenoble, France, 38043
University hospital Bichat Claude Bernard
Paris, France, 75018
Saint Joseph Hospital
paris, France, 75014
University Hospital Beaujon
Paris, France, 75018

Sponsors and Collaborators

University Hospital, Grenoble

Ministry of Health, France

Investigators

Principal Investigator:	jean-francois Timsit	University Hospital, Grenoble
Study Chair:	jean-christophe Lucet, MD	University hospital Bichat, Paris, France

More Information

Additional Information:

the cover webpage will provide some information about the study status This link exits the ClinicalTrials.gov site

No publications provided by University Hospital, Grenoble

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Timsit JF, Schwebel C, Bouadma L, Geffroy A, Garrouste-Orgeas M, Pease S, Herault MC, Haouache H, Calvino-Gunther S, Gestin B, Armand-Lefevre L, Leflon V, Chaplain C, Benali A, Francais A, Adrie C, Zahar JR, Thuong M, Arrault X, Croize J, Lucet JC; Dressing Study Group. Chlorhexidine-impregnated sponges and less frequent dressing changes for prevention of catheter-related infections in critically ill adults: a randomized controlled trial. JAMA. 2009 Mar 25;301(12):1231-41.

Responsible Party:	University Hospital of Grenoble ( TIMSIT )
Study ID Numbers:	05PHN01
Study First Received:	December 28, 2006
Last Updated:	June 13, 2008
ClinicalTrials.gov Identifier:	NCT00417235 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Grenoble:

catheter related infection
catheter dressing
prevention

Chlorhexidine impregnated dressings
Infection
catheterization

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Bacterial Infections
Anti-Infective Agents
Disease
Chlorhexidine
Bacteremia
Infection
Pharmacologic Actions
Inflammation

Anti-Infective Agents, Local
Disinfectants
Sepsis
Pathologic Processes
Shock
Chlorhexidine gluconate
Therapeutic Uses
Syndrome
Dermatologic Agents

ClinicalTrials.gov processed this record on February 08, 2010